Memorandum submitted by Homeopathy: Medicine for the 21st
Century (H:MC21)

H:MC21 is a charity which promotes homeopathy.

Introduction

1. Karl Popper stated that:

... the belief that
we can start with pure observation alone, without anything in the nature of a
theory, is absurd ... Observation is always selective. It needs a chosen object,
a definite task, an interest, a point of view, a problem.([i])

Any
evidence in the field of health, therefore, should be considered in relation to
the "point of view" which provides its context. In particular there is a need
to ensure that scientifically valid definitions are used, and a theoretical
framework capable of being tested scientifically.

3. The practice of
conventional clinical medicine uses technologies derived from scientific
fields, but it operates within an empirical one:

Clinical practice must not be regarded as
applied biological medicine, and it is
necessary to adopt the empiricist approach for the solution of clinical
problems.([iii])

3.1. The definition of illness. Disease categorisation is based on the
following approach:

Doctors have studied millions of sick
people, and we must imagine that no two of these were ever completely identical
as regards their clinical pictures and the underlying causal mechanisms, but in
order to build up a medical science, it was essential to stress the
similarities rather than the differences.([iv])

Though empirically useful, this is
not scientifically sound, because:

3.1.1. Disease definitions
change over time as symptomatology and causative processes are better
understood. For example, the illness of pneumonia is now categorised as eleven
illnesses.([v])

3.1.2. Some diseases are
essentially individual, or "idiopathic".([vi])

3.2. The definition of effectiveness. There is no scientifically
justified definition, and the "effectiveness" of treatments changes
unpredictably.

3.2.1. The 'intention to
treat' means that "effectiveness" is dependent on what symptomatology is
chosen.

3.2.1.1. There is an
arbitrary divison into "desirable" effects and side effects, despite the fact
that the true effect of the drug is the combination of these.

3.2.1.2. Changing the
'intention to treat' changes the definition of "desirable" effects and side
effects, and so changes the "effectiveness", as in the case of Viagra.([vii])

3.2.1.3. The severity of side
effects in clinical practice can lead to the withdrawal of a treatment shown to
be "effective" in trials.

3.2.2. The time-scale of
trials may be insufficient for establishing the effects of a treatment.

3.2.2.1. Effects which lie
outside the time-frame will only be identified from clinical practice.

3.2.2.2. The "effectiveness"
of drugs can be redefined as a result of experience in clinical practice, as in
the case of Aspirin.([viii])

3.3. Theory of health and disease. The absence of a theory means that
processes of change in health cannot be distinguished from each other, such as:

3.3.1. The 'natural course'
of the disease from a course affected by treatment.([ix])

3.3.2. The effect of a
'placebo' from that of a curative agent.

3.3.3. Improvement in one
part of the body cannot be readily and systematically related to symptomatology
in other parts of the body.

Evidence-based Medicine

4. In the face of these
problems, medical practitioners have devloped the system of evidence-based
medicine (EBM). This involves three elements, none of which is sufficient by
itself as a basis for successful medical practice (our emphases):

Evidence-based medicine is the
conscientious, explicit, and judicious use of current best evidence in making
decisions about the care of individual patients. The practice of
evidence basedmedicine means integrating individual clinical
expertise withthe best available external clinical evidence
from systematicresearch. By individual clinical expertise we mean
the proficiencyand judgment that individual clinicians acquire
through clinicalexperience and clinical practice. Increased
expertise is reflectedin many ways, but especially in more
effective and efficientdiagnosis and in the more thoughtful
identification and compassionateuse of individual patients'
predicaments, rights, and preferencesin making clinical decisions
about their care. By best availableexternal clinical evidence we
mean clinically relevant research,often from the basic sciences of
medicine, but especially frompatient centred clinical research into
the accuracy and precisionof diagnostic tests (including the
clinical examination), thepower of prognostic markers, and the
efficacy and safety oftherapeutic, rehabilitative, and preventive
regimens. Externalclinical evidence both invalidates previously
accepted diagnostictests and treatments and replaces them with new
ones that aremore powerful, more accurate, more efficacious, and
safer.

Good doctors use both individual clinical expertise and thebest
available external evidence, and neither alone is enough.Without clinical
expertise, practice risks becoming tyrannisedby evidence, for even
excellent external evidence may be inapplicableto or inappropriate
for an individual patient. Without currentbest evidence, practice
risks becoming rapidly out of date,to the detriment of patients.([x])

4.1. Care of the individual. The purpose of medicine is successful
treatment of the individual, so evidence of what is successful in individual
cases is essential. One method of acquiring this information is outcome
studies, but these cannot provide information enabling the development of new
treatments.

4.2. Clinical expertise. Practitioners can acquire experience which
enables them to assess the differerent effects of treatments across a range of
individuals, and to target treatments based on that experience. The problem is
that this knowledge is rarely quantified, let alone rigorously quantified, and
therefore it is liable to be subjective.

4.3. External clinical evidence. Evidence about treatments gathered from
RCTs can offer some degree of objectivity about treatments, but it cannot
provide reliable information about the appropriateness of a specific treatment
to a particular individual. Thus:

There was still no guarantee that a
treatment that had succeeded during a set of trials would cure a particular
patient ...([xi])

As a result RCTs alone cannot
enable medicine to fulfil its primary purpose. RCTs are also dependent on a
scientific framework if they are to produce valid results.

4.3.1. RCTs can successfully
produce reliable evidence of the harmful effects of a treatment because:

4.3.1.1. A scientifically
valid definition of outcome is simply the increase in morbid effects or
mortality rates.

4.3.1.2. Issues of
homogeneity and generalisability are irrelevant since everyone is affected by
harmful interventions, with only the extent and rapidity of harm being
individual.

4.3.2. Evidence from RCTs
cannot prove effectiveness because:

4.3.2.1. Curative processes
are fundamentally individual, and so tests which generate statistical
likelihoods of success are not valid in an individual case (see 4.3).

4.3.2.2. There is no
scientific definition of effectiveness (see 3.2ff.).

4.3.2.3. A scientifically
valid definition of effectiveness is complex, as it needs to take into account
all the outcomes of treatment and over a significant time-scale.

4.3.2.4. The mismatch between
the definitions of diseases and their actual appearance in individuals leads to
a conflict between 'homogeneity' and 'generalisability' (see 3.1ff.).

4.3.3. Since RCTs gather
evidence in the absence of a scientific theory, the evidence cannot be checked
against predictions based on a consistent theoretical framework, but only against
other evidence gathered in the same flawed conditions.

Consequences of Evidence without Theory

5. Using an approach which is
not based on a scientific framework, but which attempts to balance different
sources of unreliable evidence in order to develop more reliable solutions,
means that there can be no certainty as to whether the correct balance has been
achieved. In addition, none of the three aspects has scientific validity in its
own right, and any tendency towards dominance of one aspect over the others
will render the approach valueless. This is a growing tendency among opponents
of homeopathy who insist on giving undue (even exclusive) weight to RCTs over
other sources of evidence.([xii],[xiii],[xiv])
As a general attitude this would lead to:

5.1. A tendency for practitioners
to ignore and fail to report adverse reactions in clinical practice on the
grounds that there is nothing in the trial literature.

5.2. A tendency for long-term
effects to go unidentified, including increases in chronic illness (as in the
analogous case of cigarettes and lung cancer). There are indications that this
is occurring:

The cost of the National Health Service
nearly trebled from 1951 to 1975 (at 1950 prices); both the consultation rate
in general practice and the hospital admission rate rose, and the waiting lists
became longer and longer.

In Denmark the experience was the same. ...

Obviously this growth has many aspects,
but it must be admitted that it is difficult to register the beneficial effect
in the available health statistics. The average expected life-span has not
changed much, and hospital waiting lists have not been eliminated.([xv])

8.2. Homeopathy was the
first medical system to test substances on healthy people prior to their use,
in order to avoid the distortions inevitable in tests on sick people.([xxiii],[xxiv])

8.3. Homeopathy was the
first medical system to seek to identify those peculiarities of the effects of
each substance which enable one to be distinguished from another.([xxv])

Application of remedies.

9. With full information
about what is to be treated and about the available medicines, there are only
three theoretical posibilities for relating one to the other:

9.1. If there is no
relationship between the bodies of information, then there is no possibility of
a science of medicine.

9.2. The bodies of
information can have no consistent relationship as opposites, because some
conditions have no opposite, but are either present or absent (for example, a
cough, pain, delusions). Again there is no possibility of a science of
medicine.

9.3. Relating the bodies of
information on the basis of similarity is possible, and so makes a science of
medicine theoretically possible. This theoretical position is evidenced in
practice, as in the case of cinchona (and its derivative quinine) which has
been used for hundreds of years in the treatment of malaria even though the
symptoms of quinine poisoning (cinchonism) closely resemble those of malaria.([xxvi])

Homeopathy uses a scientific approach to
treatment.

10. On this basis homeopathy
uses a scientifically valid approach, and confirmation can be seen in that:

10.1. Homeopathy was
developed using the scientific method, employing experiment and observation to
test and articulate its theoretical framework. This can even be seen in the
inaccurate and incomplete descriptions of opponents of homeopathy.([xxvii])

10.2. Homeopathy was the
first medical system to recognise the importance of micro-organisms in disease,
some 60 years before Koch identified the cholera bacterium.([xxviii])

10.3. Homeopathy was the
first medical system to recognise that these micro-organsms could evolve, some
30 years before Darwin published On the
Origin of Species.([xxix])

10.5. Homeopaths promoted
public hygeine before the start of the nineteenth century,([xxxi],[xxxii])
and the medical historian Simon Szreter has identified this as the primary
factor in disease reduction at the end of that century.([xxxiii])

10.6. Homeopathy was the
first medical system to identify a role for biophysics.([xxxiv])

10.7. The principles of
homeopathy are capable of being tested scientifically, as there is a consistent
theory linking selection of a treatment and analysis of the results of
treatment. Furthermore:

10.7.1. The general principles
are derived from clinical experience (see 7.3ff.).

10.7.2. Individuality is
incorporated into the theory (see 7.1 and 7.3.2).

10.7.3. It is possible to
determine what is treatable at a given point in time (see 7.3.4).

10.7.4. The results of
treatment, even in individual cases, can be measured against the general
principles (known as Hering's 'Law of Cure'), offering a scientific definition
of effectiveness.([xxxv])

10.7.5. Different outcomes can
be distinguished from each other, and an objective assessment of effectiveness
obtained.([xxxvi])

11. It is possible to produce
evidence for the effectiveness of homeopathy, but the mechanisms which have
been used offer conflicting results.

12.1. Homeopathy can
consistently define the conditions being treated.

12.2. Homeopathy can
consistently define expected outcomes.

12.3. There is no problem
with individuality in homeopathic treatment, and so no conflict between
homogeneity and generalisability.

13. However, if a homeopathic
RCT does not conform to the integrated whole of homeopathic principles, it will
produce inaccurate results.([xxxvii])

13.1. There are at least
eleven factors which can affect the results of the trial, and even reduce the
therapeutic intervention to a placebo intervention.([xxxviii])
These include:

13.1.1. Inappropriate
definitions of what is being treated.

13.1.2. Inappropriate
definitions of outcome.

13.1.3. Inappropriate
timescales.

13.2. In practice RCTs
produce ambiguous results. Moreover, positive trials are accused of being
"implausible",([xxxix])
a "stitch-up",([xl])
too small, or insufficiently rigorous, where rigour' refers to adherence to an
evidence-oriented trial structure rather than to scientific adherence to
homeopathic principles.([xli])

Meta-analyses.

14. Because meta-analyses are
based on clinical trials, and because they tend to use the same approach to
rigour, they offer no improvement in terms of evidence.

14.1. The Linde analysis
(1997) was reworked (1999) as a result of criticism based on the demands of
evidence-oriented rigour.([xlii])

14.2. The Shang analysis
(2005) also defined the rigour of the trials they selected without reference to
homeopathic principles.([xliii])

14.3. These analyses show that
a significant degree of subjectivity is introduced into the research process
using this method.([xliv])

15. In practice meta-analyses
also produce ambigiuous results, but the arguments usually focus on the
selection criteria.([xlv],[xlvi],[xlvii],[xlviii])

Outcome studies.

16. Outcome studies of
homeopathy present very different results from RCTs.

16.1. The Get Well UK study
in Northern Ireland showed health improvements in 84% of patients with GP
correlation for 65% of patients.([xlix])

16.2. The Bristol Homeopathic
Hospital study showed positive change in 70.7% of patients, with 50.7%
recording their improvement as better (+2) or much better (+3).([l])

17. Outcome studies also
measure "effectiveness" in a different area of the EBM model.

17.1. They assess the effect
of 'care of the individual'and of
'clinical expertise' (see 6ff.).

17.2. They do not constrain
the treatment process, and so do not affect the scientific integrity of this
process.

17.3. Their results can be
compared with the general tendency in the population to recover (or not) from
such conditions.

18. Typically outcome studies
show that substantial numbers of patients derive benefit from homeopathic
treatment, and often to a substantial degree.

Clinical practice.

19. Both historical and
present-day evidence of homeopathy in clinical practice reflects the results
seen in outcome studies.

19.1. A typical example is

a cholera epidemic in London in 1854,
when patients at the London Homoeopathic Hospital had a survival rate of 84 per
cent, compared to just 47 per cent for patients receiving more conventional
treatment at the nearby Middlesex Hospital.([li])

A mortality rate of 16% (at the
homeopathic hospital) is unachievable without medical intervention, whilst 53%
(at the conventional hospital) is typical without treatment.([lii],[liii])

19.3. Homeopathy has also
recently been used as a prophyactic for leptospirosis
in over 2 million people in Cuba, dramatically reducing infection and mortality
rates.([lv])

Conclusion.

20. Conventional medicine
relies on an model known as Evidence Based Medicine which balances bodies of
evidence in order to minimise the risks of harm. Within this model no form of
evidence can provide a definitive statement of effectiveness. Attempts to limit
the approach used and allow one form of evidence to dominate will defeat the object
of this model. The model is an implicit (and often explicit) recognition of the
fact that medicine has no underlying scientific theory.

21. Homeopathy has an
underlying scientific theory. This theory is consistent with observed facts, it
has led to analyses decades in advance of other medical practice, and it has a
strong body of evidence of successful practice. On this basis it is entirely
inappropriate to use the EBM model to assess its practice, let alone a single
element of that approach. Instead it should be tested by relating its clinical
practice to the predictions of its theory, as would be the case in any other
field of science. Homeopathy requires a Science Based Medicine model.

[xxxviii]
The full list is in William Alderson, Halloween Science (Stoke Ferry:
Homeopathy: Medicine for the 21st Century, 2009), pp. 57-62, available
at <http://www.homeopathyworkedforme.org/#/halloween-science/4533482584>.

[xliv]
See the commentary on this subject in William
Alderson, Halloween Science (Stoke
Ferry: Homeopathy: Medicine for the 21st Century, 2009), pp. 64-67, available
at <http://www.homeopathyworkedforme.org/#/halloween-science/4533482584>.

[xlvii]
R. Lüdtke and A.L.B. Rutten, 'The conclusions on
the effectiveness of homeopathy highly depend on the set of analyzed trials', J. Clin. Epidemiol., (2008) at
<http://www.aekh.at/fileadmin/Bilder/Hom_opathie_int/LuedtkeRuttenJCE08.pdf>.